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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceHYALGAN
Generic NameAcid, hyaluronic, intraarticular
ApplicantFIDIA FARMACEUTICI SPA
VIA PONTE DELLA FABBRICA 3/A
ABANO TERME, PADUA (PD) 35031
PMA NumberP950027
Supplement NumberS011
Date Received02/20/2008
Decision Date05/23/2008
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR UPDATING THE SECTION OF ADVERSE EVENTS WITH A QUALITATIVE DESCRIPTION OF THE TYPES AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY, AND TO SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.
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